US20070287880A1 - Intra-ventricular cardiac assist device and related method of use - Google Patents
Intra-ventricular cardiac assist device and related method of use Download PDFInfo
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- US20070287880A1 US20070287880A1 US11/788,887 US78888707A US2007287880A1 US 20070287880 A1 US20070287880 A1 US 20070287880A1 US 78888707 A US78888707 A US 78888707A US 2007287880 A1 US2007287880 A1 US 2007287880A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
- A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/295—Balloon pumps for circulatory assistance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
- A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
- A61M60/554—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/841—Constructional details other than related to driving of balloon pumps for circulatory assistance
- A61M60/843—Balloon aspects, e.g. shapes or materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
- A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
Definitions
- This invention relates to cardiac assist devices and their related method of use. More particularly, the cardiac assist device is cone-shape to provide minimal pressure on the ventricular wall and sub apparatus of the mitral value while permitting optimal ejection of blood into the ventricular outflow track.
- An extracorporeal pumping unit inflates and deflates the balloon in coordination with the electrocardiogram (ECG), with a suitable neutral drive gas, such as helium.
- ECG electrocardiogram
- Electrocardiograph leads provide timing information, such as the R wave, to identify systole and a pressure sensor at the catheter tip provides arterial pressure waveforms. This information is used to time the inflation and deflation, and to assess the hemodynamic effects of the treatment.
- Intra-aortic balloons are disclosed, for example, in U.S. Pat. No. 6,468,200 to Fischi, and U.S. Pat. No. 4,692,148 to Kantrowitz, et al.
- Advantage of the present invention device and related method and system is in the provision of a specifically shaped device that is inflated within the ventricle at the end of the slow ejection phase of the beating heart.
- This phase corresponds to the ascending part of the ECG-T wave of the heart. Therefore the energy exerted by the balloon is not contradicting the natural muscle power of the beating heart but only displacing the residual volume of blood and fluid (which are the direct consequence of heart failure) at the end of the muscle contraction. Further more, the balloon is not obstructing the normal ejecting phase of the heart as it does when inflated in early systolic phase as described in the Choy et al. devices.
- an intra-aortic balloon reduces the load on the left ventricle and raises aortic pressure to increase the blood flow to the coronary and carotid arteries. This can reduce the pulmonary capillary wedge pressure by approximately 20%, and can decrease aortic systolic pressure by 10% to 20%. Mean arterial pressure can increase by 30 to 40% secondary to enhanced diastolic blood pressure, and both cardiac output and stroke volume may experience a moderate increase.
- An intra-aortic balloon may be indicated for several conditions, such as cardiogenic shock; as an adjunct to thrombolysis or percutaneous transluminal coronary angioplasty (PTCA) in acute myocardial infarction (AMI) to maintain vessel patency; prior to coronary artery bypass graft surgery in high risk patients; severe mitral regurgitation (mitral valve too loose); decompensated mitral stenosis (mitral valve too tight); as a bridge to transplant (if an organ is readily available); refractory congestive heart failure; mechanical complication of AMI, i.e., mitral regurgitation due to papillary involvement or ventricular septal defect; or unstable angina refractory to medical therapy.
- AMI acute myocardial infarction
- the present invention provides an intra-ventricular cardiac-assist system.
- the system of the invention includes a slender flexible catheter having an inflatable balloon mounted near the distal end.
- the proximal end of the catheter is connected to a control unit containing a bladder in fluid communication with the balloon via a lumen in the catheter.
- a bidirectional pump in the control unit conducts a fluid, such as helium gas, between the bladder and the balloon in order to effect intermittent inflation of the balloon.
- the control unit further includes a processor that receives electrical signals from electrodes and a pressure sensor disposed at the distal end the catheter.
- the processor is configured to analyze the signals and to operate the pump so as to coordinate inflation and deflation of the balloon with the cardiac cycle, and to achieve predetermined intra-ventricular systolic and diastolic blood pressure.
- the electrodes contact the wall of the heart and generate signals indicative of the electrical activity that are input to the processor.
- The-processor is configured to analyze the signals and to identify the ascending part of the T wave of the ECG.
- the processor activates the pump to transfer fluid from the bladder to the balloon so as to inflate the balloon at the beginning of the T wave corresponding to the end of the slow ejection phase of the left ventricle pressure curve.
- the residual volume of blood left in the left ventricle is displaced through the aortic valve to achieve complete emptying of the left ventricle, increasing the stroke volume and generating additional systolic wave referred to herein as “systolic augmentation”.
- The-processor is also configured to analyze the signals and to identify the descending part of the T wave. When the descending part of the T wave has been identified by the processor, the processor activates the pump to transfer fluid from the balloon to the bladder so as to deflate the balloon just prior to the dicrotic notch.
- the system and method of the invention may be indicated for any condition indicated for treatment with an intra-aortic balloon.
- the system and method of the invention may also be indicated, for example, in individuals suffering from end stage left ventricular failure.
- the present invention provides a system for cardiac assist of a heart comprising:
- the invention also provides an intra-ventricular balloon for use in the system of the invention.
- the invention further provides a method for cardiac assist of a heart comprising:
- FIG. 1A shows an intra-ventricular device according to the invention in an un-inflated state and FIG. 1B is a schematic illustration of the related intra-ventricular cardiac assist system;
- FIG. 2 shows the intra-ventricular device of the system in FIG. 1 in an inflated state
- FIG. 3A and FIG. 3B shows positioning of the intra-ventricular device of FIG. 1 in a left ventricle, more particularly FIG. 3A illustrates the device in an un-inflated state and FIG. 3B illustrates the device in an inflated state;
- FIG. 4 shows the inflation-deflation cycle of the intra-ventricular device and related system according to the invention in relation to the ECG signal (C) and in relation to left ventricular (A) and aortic (B) pressure;
- FIG. 5A shows an intra-ventricular device in an un-inflated state in accordance with another embodiment of the invention and FIG. 5B is a schematic illustration of the related intra-ventricular cardiac assist system;
- FIG. 6A and FIG. 6B shows the combination of the intra-ventricular balloon (“IVB”) with intra aortic balloon (“IAB”).
- IVB intra-ventricular balloon
- IAB intra aortic balloon
- FIG. 6A illustrates the deflated IVB and inflated IAB (diastolic phase); and
- FIG. 6B illustrates the inflated IVB and deflated IAB. (late systolic phase); and
- FIG. 7 shows positioning of the intra-ventricular device of FIG. 1 in a right ventricle.
- intra-ventricular device and intra-ventricular balloon are used interchangeably and are meant to have the same meaning unless otherwise stated.
- FIG. 1A shows an intra-ventricular balloon and FIG. 1B the related system, generally indicated by 9 , in accordance with one embodiment of the invention.
- the system 9 includes a slender flexible catheter 10 with a proximal end 2 and a distal end 3 .
- An inflatable balloon 7 is mounted on the catheter 10 near the distal end 3 .
- the balloon 7 is shown in FIG. 1A in its deflated state and compactly folded onto the outer surface of the catheter 10 .
- the catheter has an outer tubular member 15 and an inner tubular member 17 coaxial with the outer tubular member 15 .
- the balloon 7 is mounted onto the outer tubular member 15 in air tight seals 19 that may be formed, for example, using an adhesive.
- the outer tubular member 15 has an annular lumen 4 and the wall of the outer tubular member is perforated with a plurality of apertures 14 in the segment of the outer tubular member 15 upon which the balloon 7 is mounted, so that the lumen of the balloon 7 and the lumen 4 are in fluid communication.
- the inner tubular member 17 has a distal end that extends beyond the distal end of outer tubular member 15 .
- a pair of spaced apart electrodes 5 , 5 ′ is disposed at the distal end 3 of the catheter 10 in the portion of the inner tubular member 17 extending beyond the distal end of the outer tubular member 15 .
- a pressure transducer 8 is disposed between the electrodes 5 , 5 ′.
- a coupling 13 having a fluid supply port 11 and electric terminals 12 .
- Individual lead wires 21 are helically wound along the luminal surface of the catheter 10 and connect each of the electrodes 5 , 5 ′ and the pressure transducer 8 to terminals in the plug 12 .
- the system 9 also includes a control unit 20 .
- the control unit 20 includes a fluid port 22 and an electrical socket 24 .
- the fluid port 22 of the control unit is adapted to mate with the fluid port 11 of the catheter 10 .
- a locking nut 26 associated with the port 11 screws onto an outer threaded surface of the port 22 to create a fluid tight seal between the ports 11 and 22 .
- the electrical socket 24 is adapted to mate with the plug 12 of the catheter 10 .
- the fluid port 22 is in fluid communicating with a bladder 28 inside the control unit 20 via a tube 30 .
- the bladder 28 functions as a fluid reservoir.
- the bladder 28 , the tube 30 , the lumen 4 and the balloon 7 thus form a closed fluid conduction system when the ports 11 and 22 are mated.
- the fluid conduction system is provided with a volume of a fluid, that may be, for example, helium gas.
- a bidirectional pump 32 conducts fluid in the fluid conduction system between the bladder 28 and the balloon 7 . When fluid is conducted by the pump 32 from the bladder 28 to the balloon 7 , the balloon 7 inflates while the bladder 28 deflates. When fluid is conducted by the pump 32 from the balloon 7 to the bladder 28 , the bladder 28 inflates while the balloon 7 deflates.
- the control unit 20 further includes a processor 34 .
- the processor 34 receives electrical signals from the electrodes 5 and 5 ′ and the pressure sensor 8 via the leads 21 in the catheter 10 and leads 36 in the control unit 20 when the plug 12 is mated with the socket 24 .
- the processor 34 is configured to analyze the signals and to operate the pump 32 via a control line 40 , so as to coordinate inflation and deflation of the balloon 7 with the cardiac cycle, as explained below.
- a power supply 42 such as a battery, provides electrical power to the processor 34 and the pump 32 .
- the balloon 7 may be made from any fluid impervious material, and may have any shape, as required in any particular application.
- the shape of the balloon 7 is preferably selected so as to avoid interference with the sub-apparatus of the mitral valve or the semi-lunar valve.
- the balloon 7 when inflated has a shape comprising a proximal hemispherical portion 40 and a distal conical portion 42 . This shape approximates the lumen of the left ventricle.
- This predetermined ice cream cone shape allows the following advantages: a) minimal interference with the submitral apparatus as well as the semilunar valve. b) minimal pressure on the left ventricular wall. c) maximal ejection force directed toward left ventricular outflow tract, to facilitate perfect emptying of the left ventricle.
- the distal end of a guide wire is inserted into the femoral artery of an individual and navigated through the arterial system to the aorta and then into the left ventricle via the aortic semilunar valve.
- the proximal end of the guide wire is then inserted into the distal end of the lumen of the inner tubular member 17 and slid to the proximal end of the catheter 10 .
- the catheter 10 with the balloon 7 deflated and compactly folded around it, is then guided along the guide wire until the balloon 7 is positioned in the left ventricle.
- FIGS. 3A and 3B shows proper positioning of the distal end 3 of the catheter 10 in the left ventricle 48 of a heart 53 , only a portion of which is shown in FIGS. 3A and 3B .
- the catheter 10 passes through the aorta 51 , through the semilunar aortic valve 52 and into the left ventricle 48 .
- the left ventricle is separated from the left atrium 54 by the mitral valve 53 .
- the balloon 7 is shown in FIG. 3A positioned in the left ventricle 48 in its deflated state. As the balloon 7 is brought into the position in the left ventricle the electrodes 5 and 5 ′ contact the wall of the left ventricle.
- signals indicative of the electrical activity are generated that are input to the processor 34 .
- This provides an indication that the distal end 3 of the catheter 10 is properly positioned in the left ventricle.
- the catheter may be properly positioned without recourse to x-ray images of the catheter.
- the guide wire is withdrawn from the individual's body through the lumen of the tubular member 17 .
- the processor 34 is configured to analyze the ECG signals generated across the electrodes 5 and 5 ′ and to identify a first predetermined feature of each heartbeat form.
- the processor activates the pump 32 to transfer fluid from the bladder 28 to the balloon 7 so as to inflate the balloon.
- the first predetermined feature is the beginning of the T wave.
- the tip of the conical portion 42 is situated at the apex of the left ventricle 48 .
- the middle portion of the balloon 7 is situated in the mid portion of the ventricle in such a way as to avoid interference with the sub-apparatus of the mitral valve. Any inflation prior to the end of the slow ejection phase would result in decreased cardiac output, and rather than increased output.
- the processor 34 is also configured to analyze the ECG signals across the electrodes 5 and 5 ′ and to identify a second predetermined feature in each heartbeat form. When the second predetermined feature has been identified by the processor, the processor activates the pump 32 to transfer fluid from the balloon 7 to the bladder 28 so as to deflate the balloon.
- the second predetermined feature is descending part of the T wave just prior to the dicrotic notch.
- the proximal part of the electrodes can be connected to a pacemaker box.
- the pacemaker When a patient has a heart block or goes into cardiac arrest the pacemaker can be activated and instant pacing achieved. This instantaneous activation is expected to enhance survival of these conditions and circumstances.
- the processor can then identify the T-Wave signals and LV assistance through the IVB and IVA/IAB is accomplished.
- FIG. 4 shows the pumping cycle of the balloon 7 , in relation to the ECG signal, in accordance with a preferred embodiment of the invention.
- the curve labeled A shows the left ventricular pressure
- the curve labeled B shows the aortic pressure
- the curve labeled C shows the ECG signal.
- a typical heartbeat form 40 of an ECG signal has a P wave 41 , a QRS complex 42 , and a T wave. 43 .
- the left ventricular pressure curve 44 has a first spike 45 , following the P wave 41 , that is followed by a second larger spike 46 extending from the QRS complex 42 until after the T wave 43 .
- the aortic pressure curve 50 rises during the rapid ejection phase 49 of the left ventricular pressure curve 44 .
- the balloon 7 is inflated at the beginning of the T-wave which corresponds to the end of the slow ejection phase of the left ventricular pressure curve (the point A in FIG. 4 )
- the residual volume of blood in the left ventricle is displaced through the aortic valve to the aorta generating a second peak in the aortic pressure, referred to herein as “systolic augmentation”. 47 .
- deflation of the balloon 7 commences at the peak of the T-wave which corresponds to the peak of the systolic augmentation (the point B).
- a healthy left ventricle typically ejects in each cycle 60-70% of the blood received from the left atrium through the mitral valve.
- a failing left ventricle may eject as little as 20-30% of the received blood in each cycle, a condition known as “left ventricular failure”.
- the balloon 7 By inflating the balloon 7 at the end of the slow ejection phase, (the point A) the residual volume in the left ventricle is displaced through the aortic valve to the aorta generating the systolic augmentation. This leads to an increase in cardiac output that may be as high as 100%.
- the volume of the inflated balloon is preferably to match perfectly the left ventricle size and shape to optimize the augmentation and prevent floating of the balloon.
- the volume of the balloon 7 when inflated is determined in accordance with the volume of the left ventricle, and is typically in the range of 40-60 ml.
- the processor 34 receives signals indicative of the intra-ventricular pressure from the pressure transducer 8 .
- the signals received by the processor from the pressure transducer 8 allow the processor to monitor the blood pressure.
- the processor is configured to adjust the activity of the pump 32 to regulate the inflation volume of the balloon, the inflation rate, and the deflation rate in order to achieve predetermined intra-ventricular systolic and diastolic pressures.
- the predetermined pressures may be input to the processor using an input device such as a keyboard 43 .
- the fluid pressure inside the inflated balloon is typically around 9-10 psi.
- the processor 34 is configured to identify the occurrence of cardiac arrest.
- the system 9 is adapted to apply voltages across the electrodes 5 and 5 ′ in order to pace the heart when cardiac arrest occurs.
- the pump 32 can be implanted under the skin and provided with a wireless, rechargeable mechanism. In a preferred embodiment, the pump is portable and rechargeable. As mentioned it can be implanted under the skin for chronic use in end stage left ventricular failure.
- FIG. 5A shows an intra-ventricular balloon and FIG. 5B illustrates the related system, generally indicated by 59 , in accordance with another embodiment of the invention.
- the system 59 has several components in common with the system 9 , and similar components in the two systems are indicated by the same reference numeral without further comment.
- the system 59 includes a slender flexible catheter 10 ′ with a proximal end 2 ′ and a distal end 3 ′.
- the system 59 includes the inflatable balloon 7 mounted on the catheter 10 ′ near the distal end 3 ′.
- the system 59 includes a second inflatable balloon 60 mounted on the catheter 10 ′ proximally to the balloon 7 .
- the balloons 7 and 60 are shown in FIG.
- the balloons 7 and 60 are spaced apart along the catheter 10 ′; so that the distal balloon 7 can be positioned in the left ventricle, as explained above in reference to the system 9 , while the balloon 60 is positioned in the descending aorta.
- the balloons 7 and 60 are mounted onto the outer tubular member 15 ′ in air tight seals 19 that may be formed, for example, using an adhesive.
- the catheter 10 ′ has an outer tubular member 15 ′ containing three lumens.
- a lumen 62 is perforated with a plurality of apertures 14 in the segment of the lumen 62 upon which the balloon 7 is mounted, so that the lumen of the balloon 7 and the lumen 62 are in fluid communication.
- a lumen 64 is perforated with a plurality of apertures 14 ′ in the segment of the lumen 64 upon which the balloon 60 is mounted, so that the lumen of the balloon 60 and the lumen 64 are in fluid communication
- the system 59 also includes a control unit 20 ′.
- the control unit 20 ′ includes a fluid port 22 ′ and the electrical socket 24 .
- the fluid port 22 ′ of the control unit is adapted to mate with a fluid port 11 ′ of the catheter 10 ′.
- a locking nut 26 associated with the port 11 ′ screws onto an outer threaded surface of the port 22 to create a fluid tight seal between the ports 11 ′ and 22 ′.
- the electrical socket 24 is adapted to mate with the plug 12 of the catheter 10 .
- the lumens 62 and 64 of the catheter 10 are in fluid communicating with the bladder 28 inside the control unit 20 ′ via a first tube 30 a and a second tube 30 b , respectively.
- the bladder 28 of the system 59 functions as a fluid reservoir.
- the bladder 28 , the tube 30 a , the lumen 62 and the balloon 7 form a first closed fluid conduction system when the ports 11 ′ and 22 ′ are mated.
- the bladder 28 , the tube 30 b , the lumen 64 and the balloon 60 form a second closed fluid conduction system when the ports 11 ′ and 22 ′ are mated.
- the fluid conduction system is provided with a volume of a fluid, that may be, for example, helium gas.
- the system 59 includes a solenoid valve 66 situated where the tube 30 ′ bifurcates into the tubes 30 a and 30 b .
- the bidirectional pump 32 conducts fluid in the fluid conduction system between the bladder 28 and the balloon 7 via the tube 30 a or between the bladder 28 and the balloon 60 via the tube 30 b .
- the balloon 7 or 60 inflates while the bladder 28 deflates.
- the bladder 28 inflates while the balloon 7 or 60 deflates.
- the control unit 20 further includes a processor 34 ′.
- the processor 34 ′ receives electrical signals from the electrodes 5 and 5 ′ and the pressure sensor 8 via the leads 21 in the catheter 10 ′ and leads 36 in the control unit 20 when the plug 12 is mated with the socket 24 .
- the processor 34 is configured to analyze the signals and to operate the pump 32 via a control line 40 a , and the valve 66 via a control line 40 b so as to coordinate inflation and deflation of the balloons 7 and 60 with the cardiac cycle, as explained below.
- a power supply 42 such as a battery, provides electrical power to the processor 34 and the pump 32 , and the valve 66 .
- the balloons 7 and 60 may be made from any fluid impervious material, and may have any shape, as required in any particular application. In one preferred embodiment the balloon 7 have the shape shown in FIG. 2 .
- the balloon 60 may have any shape known in the art for intra-aortic balloons.
- the intra-aortic balloons are of a pre-determined shape and are inflated during the diasystolic phase.
- the pre-determined shape of the balloon is similar to an ice-cream cone shaped, having a hemispherical proximal end and a tapered distal end.
- the tapered distal end is preferably semi-rigid to enable proper placement within the ventricle.
- the particular shape and design of the invention device allows minimal lateral wall pressure, with most of the energy directed towards the ventricle outflow track. This optimizes the direction of blood-flow.
- the invention balloon does not use mercury to achieve neutral buoyancy at inflation.
- the perfect matching between the left ventricle and the intra-ventricular balloon (IVB) prevents floating of the balloon.
- balloons are provided to match different sizes of ventricles.
- chronic failure left ventricles can be dilated and therefore would accommodate bigger balloons in order to get optimal displacement.
- Smaller ventricles would have proportionally smaller balloons to avoid interference with mitral, aortic and left ventricular wall structures.
- the distal end of a guide wire is inserted into the femoral artery of an individual and navigated through the arterial system to the aorta and then into the left ventricle via the aortic semilunar valve.
- the proximal end of the guide wire is then inserted into the distal end of a lumen 67 of the inner tubular member 17 and slid to the proximal end of the catheter 10 ′.
- the catheter 10 ′, with the balloons 7 and 60 deflated and compactly folded around it, is then guided along the guide wire until the balloon 7 is positioned in the left ventricle and the balloon 60 is positioned in the descending aorta.
- FIGS. 6A and 6B show proper positioning of the distal end 3 of the catheter 10 ′ in the left ventricle 48 of a heart 53 , only a portion of which is shown in the figures.
- the balloons 7 and 60 are shown in FIG. 6A positioned in the left ventricle 48 and the aorta 51 , respectively, in their deflated and inflated state.
- the electrodes 5 and 5 ′ contact the wall of the left ventricle.
- signals indicative of the electrical activity are generated that are input to the processor 34 .
- the catheter 10 ′ may be properly positioned without recourse to x-ray images of the catheter.
- the guide wire is withdrawn from the individual's body through the lumen of the tubular member 17 .
- FIG. 6B illustrates the tight relationship between the ventricle and the device to achieve the advantages of minimal pressure in the ventricular wall and maximum ejection force toward the left ventricular outflow tract as well as the inability of the balloon to float.
- the processor 34 is configured to analyze the ECG signals generated across the electrodes 5 and 5 ′ and to identify a first predetermined feature of each heartbeat form, when the intra-ventricular balloon 7 is to be inflated, a second predetermined feature of each heartbeat form, when the balloon 7 is to be deflated, a third predetermined feature of each heartbeat form, when the intra-aortic balloon 60 is to be inflated, a fourth predetermined feature of each heartbeat form, when the balloon 60 is to be deflated.
- the processor activates the pump 32 and the solenoid valve 66 to transfer fluid from the bladder 28 to the balloon 7 via the tube 30 a so as to inflate the balloon 7 .
- the processor activates the pump 32 and the solenoid valve 66 to transfer fluid from the balloon 7 to the bladder 28 via the tube 30 a so as to deflate the balloon 7 .
- the processor activates the pump 32 and the solenoid valve 66 to transfer fluid from the bladder 28 to the balloon 60 via the tube 30 b so as to inflate the balloon 60 .
- the processor activates the pump 32 and the solenoid valve 66 to transfer fluid from the balloon 60 to the bladder 28 via the tube 30 b so as to deflate the balloon 7 .
- the balloons 7 and 60 are shown in FIG. 6B positioned in the left ventricle 48 and the aorta 51 , respectively, in their diastolic phase i.e.
- FIG. 6A illustrates the deflated IVB and inflated IAB.
- the balloon 7 is inflated at the end of the slow ejection phase of the left ventricular pressure (the point A in FIG. 4 ). Deflation of the balloon 7 commences at the peak of the systolic augmentation (the point B) and is complete when the left ventricular pressure is at the dicrotic notch 48 (the point C). As explained above, this timing of the inflation and deflation of the balloon 7 generates the systolic augmentation 47 .
- the intra-aortic balloon 60 begins to inflate after closure of the aortic valve (the dicrotic notch 48 , point C), and deflation occurs prior to the P wave of the subsequent heart beat (the point D in FIG. 4 ).
- the system of the invention may also be used in a right ventricle.
- the balloon 7 is inserted into a central vein and delivered to the inferior vena cava 72 or superior vena cava 74 , and from there to the right ventricle 76 .
- the balloon 7 is positioned in the right ventricle with the proximal hemispherical portion 40 below the tricuspid valve 78 that separates the right ventricle from the right atrium 88 .
- the balloon is preferably inflated at the end of the slow ejection phase corresponding to the beginning of the ECG T wave, thus displacing residual blood volume through the pulmonary valve 80 and into the main pulmonary artery 82 .
- the main pulmonary artery divides into the right pulmonary artery 84 and the left pulmonary artery 86 .
- the balloon is deflated at the peak of the systolic augmentation.
Abstract
Description
- This application claims the benefit of U.S. provisional application No. 60/794,091 filed Apr. 24, 2006, which is incorporated herein in its entirety by reference.
- This invention relates to cardiac assist devices and their related method of use. More particularly, the cardiac assist device is cone-shape to provide minimal pressure on the ventricular wall and sub apparatus of the mitral value while permitting optimal ejection of blood into the ventricular outflow track.
- It is known in the art to provide cardiac assistance by introducing a balloon into the thoracic aorta of a patient and causing the balloon to inflate during diastole and deflate during systole. An extracorporeal pumping unit inflates and deflates the balloon in coordination with the electrocardiogram (ECG), with a suitable neutral drive gas, such as helium. Electrocardiograph leads provide timing information, such as the R wave, to identify systole and a pressure sensor at the catheter tip provides arterial pressure waveforms. This information is used to time the inflation and deflation, and to assess the hemodynamic effects of the treatment. Intra-aortic balloons are disclosed, for example, in U.S. Pat. No. 6,468,200 to Fischi, and U.S. Pat. No. 4,692,148 to Kantrowitz, et al.
- U.S. Pat. Nos. 4,685,446, 4,771,765 and 4,902,273 to Choy et al. describe various heart assist devices. The Choy patents define a balloon which is inflated at the very early stages of the systolic phase and as a consequence the energy exerted is destructive. The heart muscle and the balloon are working in opposite directions, thus leading to damage of the *muscle and reduced cardiac output due to physical obstruction of the left ventricular outflow tract The shapes of the Choy devices can unexpectedly cause unpredicted damage.
- Advantage of the present invention device and related method and system is in the provision of a specifically shaped device that is inflated within the ventricle at the end of the slow ejection phase of the beating heart. This phase corresponds to the ascending part of the ECG-T wave of the heart. Therefore the energy exerted by the balloon is not contradicting the natural muscle power of the beating heart but only displacing the residual volume of blood and fluid (which are the direct consequence of heart failure) at the end of the muscle contraction. Further more, the balloon is not obstructing the normal ejecting phase of the heart as it does when inflated in early systolic phase as described in the Choy et al. devices.
- Use of an intra-aortic balloon reduces the load on the left ventricle and raises aortic pressure to increase the blood flow to the coronary and carotid arteries. This can reduce the pulmonary capillary wedge pressure by approximately 20%, and can decrease aortic systolic pressure by 10% to 20%. Mean arterial pressure can increase by 30 to 40% secondary to enhanced diastolic blood pressure, and both cardiac output and stroke volume may experience a moderate increase.
- An intra-aortic balloon may be indicated for several conditions, such as cardiogenic shock; as an adjunct to thrombolysis or percutaneous transluminal coronary angioplasty (PTCA) in acute myocardial infarction (AMI) to maintain vessel patency; prior to coronary artery bypass graft surgery in high risk patients; severe mitral regurgitation (mitral valve too loose); decompensated mitral stenosis (mitral valve too tight); as a bridge to transplant (if an organ is readily available); refractory congestive heart failure; mechanical complication of AMI, i.e., mitral regurgitation due to papillary involvement or ventricular septal defect; or unstable angina refractory to medical therapy.
- The present invention provides an intra-ventricular cardiac-assist system. The system of the invention includes a slender flexible catheter having an inflatable balloon mounted near the distal end. The proximal end of the catheter is connected to a control unit containing a bladder in fluid communication with the balloon via a lumen in the catheter. A bidirectional pump in the control unit conducts a fluid, such as helium gas, between the bladder and the balloon in order to effect intermittent inflation of the balloon.
- The control unit further includes a processor that receives electrical signals from electrodes and a pressure sensor disposed at the distal end the catheter. The processor is configured to analyze the signals and to operate the pump so as to coordinate inflation and deflation of the balloon with the cardiac cycle, and to achieve predetermined intra-ventricular systolic and diastolic blood pressure.
- When the balloon is properly positioned in the left ventricle, the electrodes contact the wall of the heart and generate signals indicative of the electrical activity that are input to the processor. The-processor is configured to analyze the signals and to identify the ascending part of the T wave of the ECG. When the ascending part of the T wave has been identified by the processor, the processor activates the pump to transfer fluid from the bladder to the balloon so as to inflate the balloon at the beginning of the T wave corresponding to the end of the slow ejection phase of the left ventricle pressure curve. The residual volume of blood left in the left ventricle is displaced through the aortic valve to achieve complete emptying of the left ventricle, increasing the stroke volume and generating additional systolic wave referred to herein as “systolic augmentation”. The-processor is also configured to analyze the signals and to identify the descending part of the T wave. When the descending part of the T wave has been identified by the processor, the processor activates the pump to transfer fluid from the balloon to the bladder so as to deflate the balloon just prior to the dicrotic notch.
- The system and method of the invention may be indicated for any condition indicated for treatment with an intra-aortic balloon. The system and method of the invention may also be indicated, for example, in individuals suffering from end stage left ventricular failure.
- Thus, in one of its aspects, the present invention provides a system for cardiac assist of a heart comprising:
-
- (a) a catheter having a proximal end and a distal end, the catheter having at least one lumen; and
- (b) an inflatable intra-ventricular balloon mounted on the catheter near the distal end of the catheter, the balloon having a lumen in fluid communication with the lumen of the catheter and being configured for inflation in a ventricle.
- The invention also provides an intra-ventricular balloon for use in the system of the invention.
- The invention further provides a method for cardiac assist of a heart comprising:
-
- (a) Providing a catheter having a proximal end and a distal end, the catheter having at least one lumen; and an inflatable balloon mounted on the catheter near the distal end of the catheter, the balloon having a lumen in fluid communication with the lumen of the catheter and being configured for inflation in a ventricle;
- (b) Delivering the balloon to a ventricle of the heart; and
- (c) During one or more cardiac cycles, transiently inflating the balloon to achieve a predetermined intra-ventricular systolic pressure.
- Other objects, features and advantages of the present invention will be apparent when the detailed description of the preferred embodiments of the invention are considered with reference to the drawings, which should be construed in an illustrative and not limiting sense.
-
FIG. 1A shows an intra-ventricular device according to the invention in an un-inflated state andFIG. 1B is a schematic illustration of the related intra-ventricular cardiac assist system; -
FIG. 2 shows the intra-ventricular device of the system inFIG. 1 in an inflated state; -
FIG. 3A andFIG. 3B shows positioning of the intra-ventricular device ofFIG. 1 in a left ventricle, more particularlyFIG. 3A illustrates the device in an un-inflated state andFIG. 3B illustrates the device in an inflated state; -
FIG. 4 shows the inflation-deflation cycle of the intra-ventricular device and related system according to the invention in relation to the ECG signal (C) and in relation to left ventricular (A) and aortic (B) pressure; -
FIG. 5A shows an intra-ventricular device in an un-inflated state in accordance with another embodiment of the invention andFIG. 5B is a schematic illustration of the related intra-ventricular cardiac assist system; -
FIG. 6A andFIG. 6B shows the combination of the intra-ventricular balloon (“IVB”) with intra aortic balloon (“IAB”).FIG. 6A illustrates the deflated IVB and inflated IAB (diastolic phase); andFIG. 6B illustrates the inflated IVB and deflated IAB. (late systolic phase); and -
FIG. 7 shows positioning of the intra-ventricular device ofFIG. 1 in a right ventricle. - In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non-limiting example only, with reference to the drawings.
- As used in the specification herein the terms intra-ventricular device and intra-ventricular balloon are used interchangeably and are meant to have the same meaning unless otherwise stated.
-
FIG. 1A shows an intra-ventricular balloon andFIG. 1B the related system, generally indicated by 9, in accordance with one embodiment of the invention. Thesystem 9 includes a slenderflexible catheter 10 with aproximal end 2 and adistal end 3. Aninflatable balloon 7, to be described in detail below, is mounted on thecatheter 10 near thedistal end 3. Theballoon 7 is shown inFIG. 1A in its deflated state and compactly folded onto the outer surface of thecatheter 10. The catheter has anouter tubular member 15 and aninner tubular member 17 coaxial with the outertubular member 15. Theballoon 7 is mounted onto the outertubular member 15 in air tight seals 19 that may be formed, for example, using an adhesive. The outertubular member 15 has anannular lumen 4 and the wall of the outer tubular member is perforated with a plurality ofapertures 14 in the segment of the outertubular member 15 upon which theballoon 7 is mounted, so that the lumen of theballoon 7 and thelumen 4 are in fluid communication. - The
inner tubular member 17 has a distal end that extends beyond the distal end of outertubular member 15. A pair of spaced apartelectrodes distal end 3 of thecatheter 10 in the portion of theinner tubular member 17 extending beyond the distal end of the outertubular member 15. Apressure transducer 8 is disposed between theelectrodes proximal end 2 of the catheter is acoupling 13 having afluid supply port 11 andelectric terminals 12.Individual lead wires 21 are helically wound along the luminal surface of thecatheter 10 and connect each of theelectrodes pressure transducer 8 to terminals in theplug 12. - The
system 9 also includes acontrol unit 20. Thecontrol unit 20 includes afluid port 22 and anelectrical socket 24. Thefluid port 22 of the control unit is adapted to mate with thefluid port 11 of thecatheter 10. A lockingnut 26 associated with theport 11 screws onto an outer threaded surface of theport 22 to create a fluid tight seal between theports electrical socket 24 is adapted to mate with theplug 12 of thecatheter 10. - The
fluid port 22 is in fluid communicating with abladder 28 inside thecontrol unit 20 via atube 30. Thebladder 28 functions as a fluid reservoir. Thebladder 28, thetube 30, thelumen 4 and theballoon 7 thus form a closed fluid conduction system when theports bidirectional pump 32 conducts fluid in the fluid conduction system between thebladder 28 and theballoon 7. When fluid is conducted by thepump 32 from thebladder 28 to theballoon 7, theballoon 7 inflates while thebladder 28 deflates. When fluid is conducted by thepump 32 from theballoon 7 to thebladder 28, thebladder 28 inflates while theballoon 7 deflates. - The
control unit 20 further includes aprocessor 34. Theprocessor 34 receives electrical signals from theelectrodes pressure sensor 8 via theleads 21 in thecatheter 10 and leads 36 in thecontrol unit 20 when theplug 12 is mated with thesocket 24. Theprocessor 34 is configured to analyze the signals and to operate thepump 32 via acontrol line 40, so as to coordinate inflation and deflation of theballoon 7 with the cardiac cycle, as explained below. Apower supply 42, such as a battery, provides electrical power to theprocessor 34 and thepump 32. - The
balloon 7 may be made from any fluid impervious material, and may have any shape, as required in any particular application. The shape of theballoon 7 is preferably selected so as to avoid interference with the sub-apparatus of the mitral valve or the semi-lunar valve. In one preferred embodiment shown inFIG. 2 , theballoon 7 when inflated has a shape comprising a proximalhemispherical portion 40 and a distalconical portion 42. This shape approximates the lumen of the left ventricle. This predetermined ice cream cone shape allows the following advantages: a) minimal interference with the submitral apparatus as well as the semilunar valve. b) minimal pressure on the left ventricular wall. c) maximal ejection force directed toward left ventricular outflow tract, to facilitate perfect emptying of the left ventricle. - In order to deliver the
balloon 7 to the left ventricle, the distal end of a guide wire is inserted into the femoral artery of an individual and navigated through the arterial system to the aorta and then into the left ventricle via the aortic semilunar valve. The proximal end of the guide wire is then inserted into the distal end of the lumen of theinner tubular member 17 and slid to the proximal end of thecatheter 10. Thecatheter 10, with theballoon 7 deflated and compactly folded around it, is then guided along the guide wire until theballoon 7 is positioned in the left ventricle. -
FIGS. 3A and 3B shows proper positioning of thedistal end 3 of thecatheter 10 in theleft ventricle 48 of aheart 53, only a portion of which is shown inFIGS. 3A and 3B . Thecatheter 10 passes through theaorta 51, through the semilunaraortic valve 52 and into theleft ventricle 48. The left ventricle is separated from theleft atrium 54 by themitral valve 53. Theballoon 7 is shown inFIG. 3A positioned in theleft ventricle 48 in its deflated state. As theballoon 7 is brought into the position in the left ventricle theelectrodes processor 34. This provides an indication that thedistal end 3 of thecatheter 10 is properly positioned in the left ventricle. Thus, the catheter may be properly positioned without recourse to x-ray images of the catheter. After proper positioning of the balloon in the left ventricle, as shown inFIG. 3A , the guide wire is withdrawn from the individual's body through the lumen of thetubular member 17. - The
processor 34 is configured to analyze the ECG signals generated across theelectrodes processor 34, the processor activates thepump 32 to transfer fluid from thebladder 28 to theballoon 7 so as to inflate the balloon. In a preferred embodiment of the invention, the first predetermined feature is the beginning of the T wave. When theballoon 7 has the inflated shape described above in reference toFIG. 2 , the inflated balloon is positioned in theleft ventricle 48 with thehemispherical portion 40 just below the aorticsemi-lunar valve 52 inFIG. 3B . The tip of theconical portion 42 is situated at the apex of theleft ventricle 48. The middle portion of theballoon 7 is situated in the mid portion of the ventricle in such a way as to avoid interference with the sub-apparatus of the mitral valve. Any inflation prior to the end of the slow ejection phase would result in decreased cardiac output, and rather than increased output. Theprocessor 34 is also configured to analyze the ECG signals across theelectrodes pump 32 to transfer fluid from theballoon 7 to thebladder 28 so as to deflate the balloon. In a preferred embodiment of the invention, the second predetermined feature is descending part of the T wave just prior to the dicrotic notch. - In a preferred embodiment the proximal part of the electrodes can be connected to a pacemaker box. When a patient has a heart block or goes into cardiac arrest the pacemaker can be activated and instant pacing achieved. This instantaneous activation is expected to enhance survival of these conditions and circumstances. The processor can then identify the T-Wave signals and LV assistance through the IVB and IVA/IAB is accomplished.
-
FIG. 4 shows the pumping cycle of theballoon 7, in relation to the ECG signal, in accordance with a preferred embodiment of the invention. As illustrated in the figure, the curve labeled A shows the left ventricular pressure, the curve labeled B shows the aortic pressure and the curve labeled C shows the ECG signal. Atypical heartbeat form 40 of an ECG signal has aP wave 41, aQRS complex 42, and a T wave. 43. The leftventricular pressure curve 44 has afirst spike 45, following theP wave 41, that is followed by a secondlarger spike 46 extending from theQRS complex 42 until after theT wave 43. Theaortic pressure curve 50 rises during therapid ejection phase 49 of the leftventricular pressure curve 44. As explained above, in a preferred embodiment of the invention, theballoon 7 is inflated at the beginning of the T-wave which corresponds to the end of the slow ejection phase of the left ventricular pressure curve (the point A inFIG. 4 ) As a consequence, the residual volume of blood in the left ventricle is displaced through the aortic valve to the aorta generating a second peak in the aortic pressure, referred to herein as “systolic augmentation”. 47. Also in accordance with a preferred embodiment of the invention, deflation of theballoon 7 commences at the peak of the T-wave which corresponds to the peak of the systolic augmentation (the point B). This allows the pressure to drop in the left ventricle to facilitate closure of the aortic valve is at the dicrotic notch 48 (the point C). Deflation of the balloon is completed at the end of the T-wave which corresponds to the dicrotic notch (aortic valve closure) 48. - A healthy left ventricle typically ejects in each cycle 60-70% of the blood received from the left atrium through the mitral valve. A failing left ventricle may eject as little as 20-30% of the received blood in each cycle, a condition known as “left ventricular failure”. By inflating the
balloon 7 at the end of the slow ejection phase, (the point A) the residual volume in the left ventricle is displaced through the aortic valve to the aorta generating the systolic augmentation. This leads to an increase in cardiac output that may be as high as 100%. The volume of the inflated balloon is preferably to match perfectly the left ventricle size and shape to optimize the augmentation and prevent floating of the balloon. - The volume of the
balloon 7 when inflated is determined in accordance with the volume of the left ventricle, and is typically in the range of 40-60 ml. Theprocessor 34 receives signals indicative of the intra-ventricular pressure from thepressure transducer 8. The signals received by the processor from thepressure transducer 8 allow the processor to monitor the blood pressure. The processor is configured to adjust the activity of thepump 32 to regulate the inflation volume of the balloon, the inflation rate, and the deflation rate in order to achieve predetermined intra-ventricular systolic and diastolic pressures. The predetermined pressures may be input to the processor using an input device such as akeyboard 43. The fluid pressure inside the inflated balloon is typically around 9-10 psi. - In a preferred embodiment, the
processor 34 is configured to identify the occurrence of cardiac arrest. Thesystem 9 is adapted to apply voltages across theelectrodes pump 32 can be implanted under the skin and provided with a wireless, rechargeable mechanism. In a preferred embodiment, the pump is portable and rechargeable. As mentioned it can be implanted under the skin for chronic use in end stage left ventricular failure. -
FIG. 5A shows an intra-ventricular balloon andFIG. 5B illustrates the related system, generally indicated by 59, in accordance with another embodiment of the invention. Thesystem 59 has several components in common with thesystem 9, and similar components in the two systems are indicated by the same reference numeral without further comment. Thesystem 59 includes a slenderflexible catheter 10′ with aproximal end 2′ and adistal end 3′. As with thesystem 9, thesystem 59 includes theinflatable balloon 7 mounted on thecatheter 10′ near thedistal end 3′. In addition, thesystem 59 includes a secondinflatable balloon 60 mounted on thecatheter 10′ proximally to theballoon 7. Theballoons FIG. 5 in their deflated state and compactly folded onto the outer surface of thecatheter 10′. Theballoons catheter 10′; so that thedistal balloon 7 can be positioned in the left ventricle, as explained above in reference to thesystem 9, while theballoon 60 is positioned in the descending aorta. Theballoons tubular member 15′ in air tight seals 19 that may be formed, for example, using an adhesive. Thecatheter 10′ has anouter tubular member 15′ containing three lumens. Alumen 62 is perforated with a plurality ofapertures 14 in the segment of thelumen 62 upon which theballoon 7 is mounted, so that the lumen of theballoon 7 and thelumen 62 are in fluid communication. Alumen 64 is perforated with a plurality ofapertures 14′ in the segment of thelumen 64 upon which theballoon 60 is mounted, so that the lumen of theballoon 60 and thelumen 64 are in fluid communication - The
system 59 also includes acontrol unit 20′. Thecontrol unit 20′ includes afluid port 22′ and theelectrical socket 24. Thefluid port 22′ of the control unit is adapted to mate with afluid port 11′ of thecatheter 10′. A lockingnut 26 associated with theport 11′ screws onto an outer threaded surface of theport 22 to create a fluid tight seal between theports 11′ and 22′. Theelectrical socket 24 is adapted to mate with theplug 12 of thecatheter 10. - The
lumens catheter 10 are in fluid communicating with thebladder 28 inside thecontrol unit 20′ via a first tube 30 a and asecond tube 30 b, respectively. As in thesystem 9, thebladder 28 of thesystem 59 functions as a fluid reservoir. Thebladder 28, the tube 30 a, thelumen 62 and theballoon 7 form a first closed fluid conduction system when theports 11′ and 22′ are mated. Thebladder 28, thetube 30 b, thelumen 64 and theballoon 60 form a second closed fluid conduction system when theports 11′ and 22′ are mated. The fluid conduction system is provided with a volume of a fluid, that may be, for example, helium gas. Thesystem 59 includes asolenoid valve 66 situated where thetube 30′ bifurcates into thetubes 30 a and 30 b. Depending on the position of thesolenoid valve 66, thebidirectional pump 32 conducts fluid in the fluid conduction system between thebladder 28 and theballoon 7 via the tube 30 a or between thebladder 28 and theballoon 60 via thetube 30 b. When fluid is conducted by thepump 32 from thebladder 28 to theballoon 7 or theballoon 60, theballoon bladder 28 deflates. When fluid is conducted by thepump 32 from theballoon 7 or theballoon 60 to thebladder 28, thebladder 28 inflates while theballoon - The
control unit 20 further includes aprocessor 34′. Theprocessor 34′ receives electrical signals from theelectrodes pressure sensor 8 via theleads 21 in thecatheter 10′ and leads 36 in thecontrol unit 20 when theplug 12 is mated with thesocket 24. Theprocessor 34 is configured to analyze the signals and to operate thepump 32 via acontrol line 40 a, and thevalve 66 via a control line 40 b so as to coordinate inflation and deflation of theballoons power supply 42, such as a battery, provides electrical power to theprocessor 34 and thepump 32, and thevalve 66. - The
balloons balloon 7 have the shape shown inFIG. 2 . Theballoon 60 may have any shape known in the art for intra-aortic balloons. The intra-aortic balloons are of a pre-determined shape and are inflated during the diasystolic phase. - Although it has been stated previously the timing of the inflation of the intra-ventricular device is important to the success of the invention method, the particular shape of the balloon is critical also. In preferred embodiments the pre-determined shape of the balloon is similar to an ice-cream cone shaped, having a hemispherical proximal end and a tapered distal end. The tapered distal end is preferably semi-rigid to enable proper placement within the ventricle. Upon inflation the top portion expands to the size of the entire ventricle and pushes the residual blood from the space.
- The particular shape and design of the invention device allows minimal lateral wall pressure, with most of the energy directed towards the ventricle outflow track. This optimizes the direction of blood-flow.
- In contrast to known heart assist devices as described in the Choy et al. patents the invention balloon does not use mercury to achieve neutral buoyancy at inflation. In the invention method, the perfect matching between the left ventricle and the intra-ventricular balloon (IVB) prevents floating of the balloon.
- Different sizes of the invention balloons are provided to match different sizes of ventricles. For example, chronic failure left ventricles can be dilated and therefore would accommodate bigger balloons in order to get optimal displacement. Smaller ventricles would have proportionally smaller balloons to avoid interference with mitral, aortic and left ventricular wall structures.
- In order to deliver the
balloons 7 to the left ventricle and theballoon 60 the aorta, the distal end of a guide wire is inserted into the femoral artery of an individual and navigated through the arterial system to the aorta and then into the left ventricle via the aortic semilunar valve. The proximal end of the guide wire is then inserted into the distal end of alumen 67 of theinner tubular member 17 and slid to the proximal end of thecatheter 10′. Thecatheter 10′, with theballoons balloon 7 is positioned in the left ventricle and theballoon 60 is positioned in the descending aorta. -
FIGS. 6A and 6B show proper positioning of thedistal end 3 of thecatheter 10′ in theleft ventricle 48 of aheart 53, only a portion of which is shown in the figures. Theballoons FIG. 6A positioned in theleft ventricle 48 and theaorta 51, respectively, in their deflated and inflated state. As theballoon 7 is brought into the position in the left ventricle, theelectrodes processor 34. This provides an indication that theballoon 7 is properly positioned in the left ventricle and theballoon 60 is properly positioned in the descending aorta. Thus, thecatheter 10′ may be properly positioned without recourse to x-ray images of the catheter. After proper positioning, as shown inFIG. 6A , the guide wire is withdrawn from the individual's body through the lumen of thetubular member 17. -
FIG. 6B illustrates the tight relationship between the ventricle and the device to achieve the advantages of minimal pressure in the ventricular wall and maximum ejection force toward the left ventricular outflow tract as well as the inability of the balloon to float. - Referring again to
FIG. 4 , theprocessor 34 is configured to analyze the ECG signals generated across theelectrodes intra-ventricular balloon 7 is to be inflated, a second predetermined feature of each heartbeat form, when theballoon 7 is to be deflated, a third predetermined feature of each heartbeat form, when theintra-aortic balloon 60 is to be inflated, a fourth predetermined feature of each heartbeat form, when theballoon 60 is to be deflated. When the first predetermined feature of the ECG signal has been identified by theprocessor 34, the processor activates thepump 32 and thesolenoid valve 66 to transfer fluid from thebladder 28 to theballoon 7 via the tube 30 a so as to inflate theballoon 7. When the second predetermined feature has been identified by the processor, the processor activates thepump 32 and thesolenoid valve 66 to transfer fluid from theballoon 7 to thebladder 28 via the tube 30 a so as to deflate theballoon 7. When the third predetermined feature of the ECG signal has been identified by theprocessor 34, the processor activates thepump 32 and thesolenoid valve 66 to transfer fluid from thebladder 28 to theballoon 60 via thetube 30 b so as to inflate theballoon 60. When the fourth predetermined feature has been identified by the processor, the processor activates thepump 32 and thesolenoid valve 66 to transfer fluid from theballoon 60 to thebladder 28 via thetube 30 b so as to deflate theballoon 7. Theballoons FIG. 6B positioned in theleft ventricle 48 and theaorta 51, respectively, in their diastolic phase i.e.FIG. 6A illustrates the deflated IVB and inflated IAB. - As with the
system 9, in a preferred embodiment of thesystem 59, theballoon 7 is inflated at the end of the slow ejection phase of the left ventricular pressure (the point A inFIG. 4 ). Deflation of theballoon 7 commences at the peak of the systolic augmentation (the point B) and is complete when the left ventricular pressure is at the dicrotic notch 48 (the point C). As explained above, this timing of the inflation and deflation of theballoon 7 generates thesystolic augmentation 47. Also in accordance with a preferred embodiment, theintra-aortic balloon 60 begins to inflate after closure of the aortic valve (thedicrotic notch 48, point C), and deflation occurs prior to the P wave of the subsequent heart beat (the point D inFIG. 4 ). - The system of the invention may also be used in a right ventricle. In this case, as shown in
FIG. 7 , theballoon 7 is inserted into a central vein and delivered to theinferior vena cava 72 orsuperior vena cava 74, and from there to theright ventricle 76. Theballoon 7 is positioned in the right ventricle with the proximalhemispherical portion 40 below thetricuspid valve 78 that separates the right ventricle from theright atrium 88. The balloon is preferably inflated at the end of the slow ejection phase corresponding to the beginning of the ECG T wave, thus displacing residual blood volume through thepulmonary valve 80 and into the mainpulmonary artery 82. The main pulmonary artery divides into the rightpulmonary artery 84 and the leftpulmonary artery 86. The balloon is deflated at the peak of the systolic augmentation. - The foregoing description of various and preferred embodiments of the present invention has been provided for purposes of illustration only, and it is understood that numerous modifications, variations and alterations may be made without departing from the scope and spirit of the invention as set forth in the following claims.
Claims (38)
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US11/788,887 US8221303B2 (en) | 2006-04-24 | 2007-04-23 | Intra-ventricular cardiac assist device and related method of use |
US13/550,555 US8784292B2 (en) | 2006-04-24 | 2012-07-16 | Double balloon pump cardiac assist device and related method of use |
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US11/788,887 US8221303B2 (en) | 2006-04-24 | 2007-04-23 | Intra-ventricular cardiac assist device and related method of use |
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CN102107030A (en) * | 2009-12-28 | 2011-06-29 | 杨碧波 | Cardiac impulse assist device, cardiac impulse assist system and method for treating cardiac failure |
US20110224655A1 (en) * | 2008-09-11 | 2011-09-15 | Asirvatham Samuel J | Central core multifunctional cardiac devices |
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